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NCT02336373 · ClinicalTrials.gov registry record · Phase 2
Treatment of Hemoglobin SC Disease With Hydroxyurea
A Phase 2 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT02336373: Clinical Trial Phase 2 study, sponsored by Baylor College of Medicine.
NCT02336373 is a Phase 2 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02336373, a Phase 2 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle cell disease with typically higher hemoglobin and milder or later disease complications. Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This can result in painful episodes, serious infections, and damage to body organs. One medication used to treat sickle cell disease is hydroxyurea. Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD, so less is known about how HbSC patients respond to hydroxyurea. The purpose of this research study is to see if hydroxyurea, a medication given to many children with the most common type of sickle cell, those who are homozygous for the sickle mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by giving a questionaire when the medication is started, and then every two months at a clinic visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle Cell Disease Module version 3.0, measures quality of life. The investigators will also see how hydroxyurea changes laboratory test numbers, and blood thickness.
Primary Outcome
Mean change in PedsQL™ Sickle Cell Disease Module version 3.0 score after achieving MTD compared with baseline. PedsQL™ Sickle Cell Disease Module version 3.0 scores are on a 100 point scale ranging from 0 to 100 with higher values indicating better quality of life. PedsQL: pediatric qulaity of life
Interventions
- DRUG hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
Why NCT02336373 stopped before completion
NCT02336373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which hydroxyurea is the first listed.
NCT02336373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02336373 about?
NCT02336373 is a clinical study titled "Treatment of Hemoglobin SC Disease With Hydroxyurea". Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle cell disease with typically higher hemoglobin and milder or later disease complications. Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This can result in painful ep...
What is the current status of trial NCT02336373?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2014-12. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02336373?
The interventions under investigation include: hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT02336373?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02336373's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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